Juul devices cited in seizure reports that triggered FDA probe



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An investigation by U.S. health authorities into the e-cigarettes can cause seizures by a handful of people who reportedly used Juul devices, according to the Food and Drug Administration documents.

The three seizures reported by the FDA's online safety portal, and the agency was not able to verify that they were tied to Juul devices. While the company's e-cigarette dominates the market for the devices, its name is also used as a substitute by some people for any type of vaping.

"No proof of causality, but at a minimum, an association with Juul," Mitch Zeller, director of the FDA's Center for Tobacco Products, emailed then-FDA Commissioner Scott Gottlieb on Oct. 15. The agency's communications about Juul were obtained by Bloomberg through a public-records request. The FDA has been established, and Bloomberg's report is the first confirmation that they have specifically used a Juul device.

The probe by FDA tobacco regulators in the reports began as early as October, six months before the agency went public with a wider warning. Regulators at the agency uses the reporting system as an early warning system for drugs, medical devices and tobacco products. A small number of reports can trigger a wider probe to determine whether a problem is widespread or serious.

Hot Startup

Juul's device is made by Juul Labs Inc. The vaping startup has advertised itself as a traditional smokers, and has attracted a $ 13 billion investment from Altria Group Inc. on its way to dominating the market.

"Juul spokesman Matt David said in a statement," We will be vigilantly monitoring for any evidence of safety and working cooperatively.

The San Francisco-based company has attracted scrutiny to the devices as well as to become popular with teens and others. Today, the Wall Street Journal reported that the US Federal Trade Commission had opened an investigation into the company's marketing practices. Juul has taken steps to try and curb such use.

Cigarettes are responsible for more than 480,000 deaths in the US, according to the Centers for Disease Control and Prevention. Eliminating or curtailing their use would be vastly improved, although they are likely to be sensitive to the situation.

In the case of the seizures described in the FDA documents, the agency was officially released to Juul, Zeller said in an interview with Bloomberg today. The FDA's online safety reporting often does not gather enough information to draw final conclusions and follow up can be difficult if someone does not save the product in question, take photos, or does not leave a way for investigators to contact them.

But the agency's concerns eventually grew to a level where it decided to go public. It released updates on the investigation in hopes of public information, Zeller said. Earlier this month, the agency said the investigation was widened to 127 reports of seizures or other neurological symptoms linked to e-cigarettes between 2010 and 2019. The FDA has not identified a specific product in any of its public communications.

Early Reports

In his October email to Gottlieb, Zeller briefly outlined the three reports, two parents and one of a 23-year-old man who said they thought they would be linked to their experiences. The FDA gathered another 32 reports before issuing a statement in April that was investigating a possible link.

The reports are first-hand accounts to the FDA, and their contents are not verified. One, received by FDA on June 27, 2018, says it's from a mother who said her 16-year-old had had a big bad time after using a Juul device. Her son told her he will have an after inhaling his Juul, which she did not know how to use, and then collapsed.

"From that point I have been involved in the room above me. I have been fully seizing, convulsions, turning blue, eyes rolled up in his head, "the mother said in her report. "He was unconscious once the convulsions stopped about a minute after they probably started."

Paramedics found a mint-flavored Juul under the collapsed teen, who later came to the ambulance, she said in her report to the FDA. The flavor pod contained 5% nicotine by weight, among the higher amounts on the market, she said.

The second report of a teenager who had a big bad life that Zeller flagged a parent of a 15-year-old boy who had been addicted to fruit-flavored Juul for a year and also used the 5% pods. The boy had developed attention problems and increased compulsiveness, according to the report.

"While doctors are not so trained for you, it's obvious that you're in the middle of the road." The teen's family wrote .

Sales Scrutiny

It has been suggested that it be faced with a number of complaints, especially those that are likely to be younger users, including the Federal Trade Commission. Juul said in a statement to Bloomberg that it cooperates with any government investigation. Shares of Altria were down 3.8% at 1:26 in New York.

Juul's sales and marketing practices have also been the target of an FDA investigation because of the device's popularity among youth. The agency seized documents from Juul's San Francisco headquarters almost a year ago.

The House Oversight and Reform Committee is also investigating Juul. The committee released a report in July. Internal emails from Juul released by the committee showed employees discussing how these programs resembled tactics used by cigarette makers in the past. In one email, a Juul employee called them "eerily similar," according to the committee's report.

Juul's school programs are the subject of "an active, ongoing investigation" by the FDA, Zeller said in the interview. He declined to comment on the active investigation of the company's marketing practices, or a separate inquiry.

Documents obtained by Bloomberg show that Juul informed the FDA as early as the spring of 2018 that it planned to contact schools to work on youth education and nicotine-use prevention efforts. Zeller said Juul described the programs as they would target administrators and teachers, not students. The company then told the agency in October it had dropped the idea, Zeller said.

"We told FDA that we were planning to talk with administrators and teachers," said David, the Juul spokesman, said. David said the program was "clearly misconstrued" and had been meant to warn youth about the danger of nicotine use.

More Concerns

Vaping has been associated with seizures but has recently been implicated in an outbreak of mystery lung diseases. The Centers for Disease Control and Prevention said Friday that it was investigating 193 possible cases of severe lung disease linked to e-cigarette use in 22 states. One adult male in Illinois has died.

Some states have said that THC, the psychoactive substance in marijuana. These authorities have made such a clear distinction, despite calls from vaping advocates for clarification.

"A lot more needs to be known," Zeller said.

Robert Redfield's Centers for Disease Control and Prevention Director tweeted Friday that there are "serious risks associated with e-cigarette products."

Former FDA Commissioner Gottlieb, who left the agency in April, said concerns about possible high-dose nicotine products were involved. Depending on the strength, the amount of nicotine in Juul pod is roughly equivalent to a pack of cigarettes.

"You can draw your own conclusions about that goal is a high-dose nicotine product," Gottlieb said in an interview. "It does not necessarily just implicate Juul. It could be other products, it could be illegal products. "

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